FDA.reportPublic FDA data

Atellica™ IM aHBcM QC

Primary DI
00630414597805
Brand
Atellica™ IM aHBcM QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10995450
Catalog number
10995450
Device description
HBc IgM (aHBcM) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Published
2018-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOMTest, hepatitis b (b core, be antigen, be antibody, b core igm)
SEIQualitative and Quantitative Hepatitis B Virus Antibody assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Microbiology2
SEIQualitative And Quantitative Hepatitis B Virus Antibody AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030040000
P030040002
P030040004
P030040005
P030040006
P030040008
P030040009
P030040010
P030040011
P030040012
P030040013
P030040014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030040000ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040002ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040004ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040005ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040006ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040008ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040009ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040010ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040011ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040012ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040013ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040014ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414597805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414597805006304145978056304145978050630414597805

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336246672Elecsys Anti-HBc IIRoche Diagnostics GmbHSEI2026-09-04
15099590806323Access anti-HBc IgM Beckman Coulter, Inc.SEI2026-05-04
15099590806330Access anti-HBc IgM CalibratorBeckman Coulter, Inc.SEI2026-05-04
15099590806347Access anti-HBc IgM QCBeckman Coulter, Inc.SEI2026-05-04
15099590806293Hepatitis B Virus core Total AntibodyBeckman Coulter, Inc.SEI2026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORBeckman Coulter, Inc.SEI2026-03-30
15099590806316ACCESS anti-HBc Total QCBeckman Coulter, Inc.SEI2026-03-30
07613336160367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-10-02
07613336230367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-08-20
00380740160579AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740160593AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740161262AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214289AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214296AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214302AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00630414637877Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2024-04-26
00630414637877Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2024-04-26
00630414561233ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414561226ADVIA Centaur® HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414561226ADVIA Centaur® HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414210766ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414210766ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604138Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414604138Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604336Atellica IM HBcT2 QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414604336Atellica IM HBcT2 QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00380740156992ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740157012ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740158187ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740163389ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13